Childrens TYLENOL

Product NDC: 50580-612
Requested package NDC: 50580-612-02
11-digit product format: 505800612
Labeler code: 50580
Product ID: 50580-612_22ef278e-cdce-0cd3-e063-6394a90af8ea
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen
Dosage form: SUSPENSION
Route: ORAL
Labeler: Kenvue Brands LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2016-08-01
Substance: ACETAMINOPHEN
Active strength: 160 mg/5mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens TYLENOL
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ACETAMINOPHEN	160 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
307668	Internal RxNorm lookup
828555	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d8aa3b1a-5f63-49db-998c-35cd11bd733f	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
50580-612-01	2024-02-06	Children's TYLENOL ®
50580-612-02	2024-02-06	Children's TYLENOL ®
50580-612-01	2024-01-30	Children's TYLENOL ®
50580-612-02	2024-01-30	Children's TYLENOL ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50580-612-01	Childrens TYLENOL	1 in 1 CARTON	SUSPENSION	1		12
50580-612-01	Childrens TYLENOL	120 mL in 1 BOTTLE	SUSPENSION	120		12
50580-612-02	Childrens TYLENOL	1 in 1 CARTON	SUSPENSION	1		12
50580-612-02	Childrens TYLENOL	2 in 1 PACKAGE	SUSPENSION	2		12
50580-612-01	Childrens Tylenol	120 mL in 1 BOTTLE	SUSPENSION	120 mL	160 mg in 5mL	11
50580-612-01	Childrens Tylenol	1 in 1 CARTON	SUSPENSION		160 mg in 5mL	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-612-01	ML - Milliliter	50580-612	05be4ab3-3116-4f04-9f29-23a4e16cf98a	1	2017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-612	CHILDRENS TYLENOL (ACETAMINOPHEN) SUSPENSION [KENVUE BRANDS LLC]	12	Current NDC, Legacy NDC, 4 package rows	20241103_d8aa3b1a-5f63-49db-998c-35cd11bd733f.zip
50580-612	CHILDRENS TYLENOL (ACETAMINOPHEN) KIT [KENVUE BRANDS LLC]	11	Current NDC, Legacy NDC	20241109_babcb210-6a47-46ef-b4ea-bdde80411cd3.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 84 · 1,678 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Relief Acetaminophen 325 mg	ACETAMINOPHEN	NUVICARE LLC	49a59b79-b8b4-4bf5-a403-0a14751efc55	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Childrens Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	4f86419a-b940-a9c6-e063-6394a90a6a2b	2026-07-30	Warnings	Exact identifier application number: M013
KinderFarms Infants Pain and Fever	ACETAMINOPHEN	KinderFarms, LLC	5468b149-8fac-8d6a-e063-6294a90a8c51	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	3ba0a9f2-062a-401e-82eb-54383a822366	2026-07-29	Warnings	Exact identifier application number: M013
Aspirin Low Dose Chewable	ASPIRIN	Better Living Brands, LLC	7afce7b4-c86a-43f7-83cf-15ebffba2f35	2026-07-28	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	f818996c-36d2-4d3d-af3e-39949157edb9	2026-07-28	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	L.N.K. International, Inc.	03b871e8-3e14-4ed8-a978-45129255b272	2026-07-27	Warnings	Exact identifier application number: M013
Pain Relief Acetaminophen PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Rite Aid Corporation	17d27771-a112-474f-9a58-29af0d7e1af3	2026-07-27	Warnings	Exact identifier application number: M013
Children Pain Relief Gummy	ACETAMINOPHEN CHILDREN GUMMY	Gummy USA	5513db67-f023-7f47-e063-6294a90a2757	2026-07-24	Warnings	Exact identifier application number: M013
Infants TYLENOL	ACETAMINOPHEN	Kenvue Brands LLC	2143cc16-86db-4060-96da-5c228ae9207b	2026-07-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Softgel Healthcare Pvt Ltd	352bb451-ffdc-411a-e063-6294a90a8cf5	2026-07-24	Warnings	Exact identifier application number: M013
acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	fdb7331a-d029-8b2a-e053-6294a90adfcd	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	5ada044e-50e8-4874-ac04-df5f1f9e735d	2026-07-24	Warnings	Exact identifier application number: M013
childrens fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	a63727c3-64d8-4ae9-8da3-974cae6beed2	2026-07-24	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Aurohealth LLC	e4a2566e-48ec-4602-87e3-143398d15f33	2026-07-24	Warnings	Exact identifier application number: M013
infants fever reducer and pain reliever	ACETAMINOPHEN	Rite Aid Corporation	920e7055-7ed1-4db4-9215-f8933078bb7b	2026-07-24	Warnings	Exact identifier application number: M013
Dye Free Pain and Fever Childrens	ACETAMINOPHEN	Walgreens	c6665c11-9a01-4472-a444-acadb1de0b69	2026-07-23	Warnings	Exact identifier application number: M013
Tylenol Extra Strength	ACETAMINOPHEN	Kenvue Brands LLC	103d109d-f520-409c-8da2-eb6b0fbec891	2026-07-22	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Kenvue Brands LLC	ce58105b-f010-47af-8f31-6dd4ce4e9cba	2026-07-22	Warnings	Exact identifier application number: M013
Vicks PainQuil PAIN RELIEVER	ACETAMINOPHEN	The Procter & Gamble Manufacturing Company	0ad7b313-5d72-4cc0-97f0-1a30770350af	2026-07-22	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
828555	Tylenol 160 MG in 5 mL Oral Suspension	PSN	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
828555	acetaminophen 32 MG/ML Oral Suspension [Tylenol]	SBD	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
307668	APAP 32 MG/ML Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
828555	APAP 32 MG/ML Oral Suspension [Tylenol]	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
828555	Tylenol 160 MG per 5 ML Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
828555	Tylenol 32 MG/ML Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
828555	Tylenol Infants 160 MG in 5 mL Oral Suspension	SY	d8aa3b1a-5f63-49db-998c-35cd11bd733f	12
313820	acetaminophen 160 MG Chewable Tablet	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 160 MG in 5 mL Oral Suspension	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	Tylenol 160 MG in 5 mL Oral Suspension	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	Tylenol Junior 160 MG Chewable Tablet	PSN	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	acetaminophen 160 MG Chewable Tablet [Tylenol]	SBD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	acetaminophen 32 MG/ML Oral Suspension [Tylenol]	SBD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
313820	acetaminophen 160 MG Chewable Tablet	SCD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 32 MG/ML Oral Suspension	SCD	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 160 MG per 5 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 320 MG per 10 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 650 MG per 20.3 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	acetaminophen 80 MG per 2.5 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
313820	APAP 160 MG Chewable Tablet	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	APAP 160 MG Chewable Tablet [Tylenol]	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
307668	APAP 32 MG/ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	APAP 32 MG/ML Oral Suspension [Tylenol]	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828557	Tylenol 160 MG Chewable Tablet	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	Tylenol 160 MG per 5 ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	Tylenol 32 MG/ML Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11
828555	Tylenol Infants 160 MG in 5 mL Oral Suspension	SY	babcb210-6a47-46ef-b4ea-bdde80411cd3	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50580-612-02	50580061202	2 CARTON in 1 PACKAGE (50580-612-02) / 1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE	2 carton	2016-10-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Children's Tylenol	Kenvue Brands LLC	2024-11-08	HUMAN OTC DRUG LABEL	11
Children's TYLENOL ®	Kenvue Brands LLC	2024-09-25	HUMAN OTC DRUG LABEL	12